Colorectal Cancer Screening, Bowel Cleansing for Colonoscopy
Conditions
Keywords
Colorectal cancer screening, Bowel cleansing for colonoscopy
Brief summary
The purpose of this research is to compare patient preferences for two bowel preparation options: low-volume tablets (Suflave/Sutab) versus the standard colon preparation using Golytely (polyethylene glycol). The study aims to enroll approximately 300 patients, who will be randomly assigned to one of the two preparation methods in a 2:1 ratio prior to their scheduled colonoscopy appointments. Surveys will be conducted both before and after the procedures. This project will be conducted over a 12-month period and seeks to compare patient experience of both preparation methods in an outpatient setting. The study will evaluate the rate of preparation completion, patient satisfaction, tolerance of the solutions, and the endoscopic adequacy of each method. Eligible participants are patients aged 18 or older with upcoming colonoscopy appointments who can provide informed consent in English or Spanish. There is no health risks associated with this study, as both bowel preparation methods are FDA-approved and commonly used in clinical practice.
Interventions
DRUGGolytely
large volume liquid prep.
DRUGSulfave
SUFLAVE is a split-dose (2-day) regimen. A total of 2 bottles are required for complete preparation for colonoscopy. You will take 2 bottles of liquid in two separate doses. One dose of SUFLAVE is equal to one bottle plus one flavor enhancing packet.
DRUGSutab
SUTAB comes in a kit that contains two medication bottles and a cup for water. Each bottle contains 12 tablets (pills). You'll take 12 pills (one bottle) with water from the cup the night before your exam. Later that evening, drink two more cups of water. Fill the cup to the line each time. Then, six hours before your exam, repeat all three of those steps.
Sponsors
Morehouse School of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults over age of 18 years undergoing outpatient colonoscopy for various indications, ability to consent in English or Spanish. Patients will still be allowed to join if there is a history of colorectal cancer or previous surgery
Exclusion criteria
* Patient is less than 18 years of age, any pregnant or nursing women, unable to consent, or patient is incarcerated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Experience | Until the end of the study | Evaluate the patient experience of the two new colon prep options (low volume and tablets) versus conventional bowel prep in an out-patient setting. |
| Edoscopic Adequacy | Until the end of the study | Assess endoscopic adequacy of the three bowel cleansing solutions |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Completion | Until the end of the study | Determine the rate of completion for each colon prep option |
Other
| Measure | Time frame | Description |
|---|---|---|
| Rate of cancellation and patient satisfaction and tolerance | Until the end of the study | Compare rate of cancelation/missed rate, patient satisfaction and tolerance for the three colon preps. |
Countries
United States
Contacts
Primary ContactJulia J Liu, MD, MSc
Backup ContactTasha Rhymes, M.S. Ed.
Outcome results
None listed